UCLA CTSI Clinical and Translational Science Institute

Steven Dubinett, MD Director, Clinical and Translational Science Institute Associate Vice Chancellor and Senior Associate Dean, Translational Research

External Advisory Board June 5, 2013

1

2

S. Claiborne Johnston, MD, PhD UC San Francisco Professor of Neurology and Epidemiology Associate Vice Chancellor of Research Director, UCSF CTSI

Sergio Aguilar-Gaxiola, MD, PhD UC Davis Director, Center for Reducing Health Disparities Community Engagement, Clinical & Translational Science Cente

Michael Becich, MD, PhD University of Pittsburgh Chair and Professor, Department of Biomedical Informatics

David Chang, MD, PhD Vice President, Amgen

Deborah Fournier, PhD Boston University Assistant Provost for Institutional Research Director, Evaluation and Tracking BU CTSI

Daniel Masys, MD University of Washington Biomedical Informatics

Eugene Orringer, MD University of North Carolina Director of Education, CTSA

William Smoyer, MD, FASN Ohio State University C. Robert Kidder Chair, Professor of Pediatrics Vice President, Clinical and Translational Research Director, Center for Clinical and Translational Research The Research Institute at Nationwide Children's Hospital

Hal F Yee, Jr., MD, PhD LA County Department of Health Services Chief Deputy Director, Health Services, Clinical and Medical Affairs

External Advisory Board

2

3

James Economou, MD, PhD Professor of Surgery Vice Chancellor for Research A. Eugene Washington, MD, M.Sc. Dean, David Geffen School of Medicine Vice Chancellor, Health Sciences

Richard Baker, MD Executive Director Urban Health Institute Chairman, Department of Ophthalmology Charles R. Drew University of Medicine and Science

Richard Casaburi, MD, PhD, E Eng Professor of Medicine, Associate Chief for Research Harbor-UCLA Medical Center

Sylvia Hurtado, PhD Professor, Education & Information Studies Head, Higher Education & Organizational Change Division Director, Higher Education Research Institute (HERI) UCLA

Mark Daniel Vice President, Research Cedars-Sinai Medical Center

William Ouchi, PhD, MBA, BA Sanford and Betty Sigoloff Distinguished Professor in Corporate Renewal UCLA

Vivek Shetty, DDS, DMD Professor, Dentistry - Oral & Maxillofacial Surgery UCLA

Internal Advisory Board

3

Create an academic home for translational science

Advance team science

Train the next generation of translational scientists

Build bi-directional community partnerships

Promote inter-institutional collaborations

UCLA CTSI Goals

4

1) Review of Program Area Goals 2) Response to EAB Recommendations 3) Progress 4) Future Plans

Program Area EAB Reporting Outline

5

Overview Outline

6

• EAB recommendations

• New Governance

• Global Initiatives

• Year in Review

• Challenges

7

EAB Recommendations

8

• Consider a governance structure that facilitates making major decisions. (i.e. budgets) - New proposal for governance

• Appears to be a dominance of School of Medicine; need better representation of other schools. - New team science awards (SON, Dentistry, Life Sciences, Engineering)

- Expand participation from other schools in governance

• UCLA has advantage of arriving late to the party. Take advantage of others’ mistakes. Consult with other CTSAs nationally. - All West Coast Consortium CTSA PIs are being invited to UCLA - Visits from UCs, Minn, Boston Univ CTSAs this year - We are visiting other CTSAs: Pitt, LSU/Tulane, Colorado, Cornell - Research Associates Program (RAP) modeled after UCI

Summary of Major EAB Recommendations

9

• Early translational research (T1 translation) appears not to be as well supported. Is this by design? - T1 research is supported by pilots, core vouchers and the Shared

Resources Consortium managed by the OVCR - New education program on translating discoveries to products

• Programs should know what specific goals and metrics define success for them.

- Informatics restructure and utilization of CTSA tools - Expansion of biostatistics to include computational biology

- Dashboard initiative

Summary of Major EAB Recommendations (continued)

10

New Governance

Former CTSI Governance

Maternal, Child & Adolescent Health

Community Engagement in

Research

Biostatistics & Clinical Data Management

Pilot & Collaborative

Research Funding

Biomedical Informatics

Clinical & Community Research

Resources

Regulatory & Ethics

Translational Technologies

Education & Career Development

Program Areas

Associate Directors

Maternal, Child & Adolescent Health

Evaluation & Tracking

Biostatistics & Clinical Data Management

Pilot & Collaborative

Research Funding

Biomedical Informatics

Community Engagement in

Research

Clinical & Community Research

Resources

Office of Investigator

Services

Translational Technologies

Education & Career Development

Executive Oversight Committee (EOC)

Internal Advisory Board

(IAB) A.E. Washington J.S. Economou

Chancellor, UCLA G. Block Institutional Steering

Committee (ISC)

External Advisory Board

(EAB)

National Center for Advancing

Translational Sciences (NCATS)

CTSI Program Director Associate Vice Chancellor

S. Dubinett

11

New CTSI Governance

External Advisory Board

Internal Advisory Board

Chancellor

Translational Column Leader

MCAH

Pilot

CTT

Clinical Column Leader

Regulatory

CCRR

Science Education Column Leader

CTSI-ED

KL2

TL1

TPTS

Institute Column Leader

OIS

Evaluation

Bioinformatics

Columns

Site Directors

Director Steven M. Dubinett

Business of Science

12

CERP

Biostatistics

Meetings

Individual Column Committees ▪ Weekly

PALM (Program Area Leaders Meeting) ▪ Bi-weekly

CTSI Column Leaders Committee ▪ Monthly

Site Directors Meeting ▪ Quarterly

IAB ▪ Twice / year

EAB ▪ Once / year

13

14

Global Initiatives

Goal 5. Collaborating with other CTSAs

UCLA CTSI IRB Reliance Review Mechanism • 20 approved and pending protocols between partners

Expansion of KL2 awards to 14 trainees and K award workshops

CTSI institutions have recruited 37 translational science faculty • 13 - UCLA • 16 - Cedars • 8 - Harbor / LA BioMed

Los Angeles Data Repository (LADR) in progress • Combined resource of de-identified, structured clinical data • Enables CTSI partners to conduct research they cannot do with their own

data

Culture Changing Initiatives

15

Goal 5. Collaborating with other CTSAs

UC Biomedical Research Acceleration Integration and Development (UC BRAID) UC Research Exchange (UC-ReX)

Engage UC • Global consent and biobanking • $2-million in supplemental funding from NCATS

University of California Center for Accelerated Innovation (CAI) • Led the $21.8-million UC BRAID submission to NHLBI for a UC-wide CAI • Speeds the transition of academic discoveries to commercial products

Culture Changing Initiatives

16

Goal 5. Collaborating with other CTSAs

Opportunities for Workforce Development

• Computational medicine • Regulatory science

• Discoveries to products

Culture Changing Initiatives

References: W. Stead et al, Academic Medicine, Vol. 84, No. 4 / April 2011 R. L. Winslow et al, Science Translational Medicine, Vol. 4, Issue 158 / Oct 2012 N. Sung et al, Science Translational Medicine, Vol. 4, Issue 150 / Sept 2012 17

18 banner “Cite It” card newsletters

UC Los Angeles

UC Davis

UC San Francisco

UC Irvine

UC San Diego

Los Angeles

UCLA xData Repository · Los Angeles Data Repository · UC Research Exchange

UC Research Exchange (UC-ReX)

Los Angeles Data Repository (LADR)

UCLA xData Repository (xDR)

19

UC Research Exchange (UC-ReX)

UC Biomedical Research Acceleration Integration and Development (UC-BRAID)

fact

s pe

r dec

isio

n

5

Adapted from W. Stead et al, Academic Medicine, Vol. 84, No. 4 / April 2011

1990 2000 2010 2020

Clinical data

Genetics and proteomics 10

100

1000

Human cognitive capacity

Proteomics Functional genetics Structural genetics Human cognitive capacity

Clinical decisions

20

Augmenting human cognitive capacity in translational research

Goal 5. Collaborating with other CTSAs

Opportunities for Workforce Development

• Computational medicine • Regulatory science

• Discoveries to products

Culture Changing Initiatives

References: W. Stead et al, Academic Medicine, Vol. 84, No. 4 / April 2011 R. L. Winslow et al, Science Translational Medicine, Vol. 4, Issue 158 / Oct 2012 N. Sung et al, Science Translational Medicine, Vol. 4, Issue 150 / Sept 2012 21

Goal 5. Collaborating with other CTSAs Translational Process

business/regulatory development consults

proof of principle

investigational new drug

clinical trials

clinical product

discovery biostatistical consults

▪ core services ▪ pilot funding

team science grants ▪ Business of Science consults

toxicology ▪ core services

consults (IND, FDA)

clinical and translational research center ▪ UC Research eXchange (UC-ReX)

22

23

Year In Review

Biostatistical Consults · Core Services · Pilot Funding · CTSI Activities

24 banner “Cite It” card posters newsletters

Quarterly publication

awards

Biostatistical Consults • 1267 projects for 611 investigators

Vouchers • Awarded 230 proposals ($2.2 M)

Pilot funding • Awarded 195 pilot grants for total of $6.45 M

($3.65 M in CTSI funds; $2.8 M institutional funds) • Return of $26 M

CTSI Activities • 20 proposals funded for total of $80 M ($88 M pending) • Rapid Response Team: supported 23 collaborations • Office of Investigator Services: 744 consults

More than 430 publications prior to January 2013

Publication awards • "Interactions Between Commensal Fungi and the C-Type Lectin

Receptor Dectin-1 Influence Colitis" | Science, June 2012 - David Underhill, PhD and Iliyan Iliev, PhD (Cedars- Sinai)

• "Diagnostic Accuracy of Fractional Flow Reserve From Anatomic CT Angiography" | JAMA, Sept 2012 - James Min, MD (Cedars-Sinai)

• "Minihepcidins prevent iron overload in a hepcidin-deficient mousemodel of severe hemochromatosis" | Blood, Nov 2012 - Thomas Ganz, MD and Emilio Ramos (UCLA)

• "Endothelial cells provide an instructive niche for the differentiation and functional polarization of M2-like macrophages" | Blood, Oct 2012

- Luisa Iruela-Arispe, PhD (UCLA)

Publications & Leveraged Funding

25

26

Challenges

• Long-term sustainability and funding environment – possible 3% rule from NCATS

• Integrate the research infrastructure across our partner institutions

Overarching Challenges

27

NIH Funding by Year (2011 – 2016)

$15,457,370

$15,079,371

$13,051,904 $14,331,847

$14,159,789

$12,000,000

$1,450,212

$0

$2,000,000

$4,000,000

$6,000,000

$8,000,000

$10,000,000

$12,000,000

$14,000,000

$16,000,000

1 2 3 4 5 6

10% cut

projected projected

projected

YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 YEAR 6 28

29

Funding Distribution by Program

LEADERSHIP 2%

OIS 8% OI

4%

BIOSTATS 7%

BIP 13%

CCRR 25%

CERP 10%

CTT 8%

ED/TPTS 4%

EVAL 4%

PILOT 10%

REG 5%

29

• KL2 expansion

• Begin planning for renewal

• Unification and utilization of the CTRC

• Training in computational medicine

• Philanthropic funding

• Partnerships with VA and LA Dept. of Health Services

• Define metrics

Year 3 High Priority Initiatives

30